BILL NUMBER: AB 1397 INTRODUCED
BILL TEXT
INTRODUCED BY Assembly Member Hill
(Principal coauthor: Senator Leno)
FEBRUARY 27, 2009
An act to amend Section 1644.5 of the Health and Safety Code,
relating to tissue donation.
LEGISLATIVE COUNSEL'S DIGEST
AB 1397, as introduced, Hill. Tissue donation.
Existing law prohibits the transfer of any tissues, as defined,
into the body of another person by means of transplantation, unless
the donor of the tissues has been screened and found nonreactive for
evidence of infection with human immunodeficiency virus (HIV), agents
of viral hepatitis (HBV and HCV), human T lymphotrophic virus-1
(HTLV-1), and syphilis, except as provided.
Existing law requires that all donors of sperm be screened and
found nonreactive under the above provisions, except as provided.
Under existing law, a sperm donor who has tested reactive for HIV or
HTLV-1 may be used for insemination or advanced reproductive
technology for a recipient who has tested negative only after
processing to minimize the infectiousness of the sperm. The State
Department of Public Health is required to adopt regulations by
January 1, 2010, regulating facilities that perform this processing.
This bill would, instead, make the adoption of the above
regulations voluntary.
Existing law further requires the physician providing insemination
or advanced reproductive technologies to, among other things, inform
the recipient that the processing may not eliminate the risk of
infection, that the sperm may be tested to ensure that it is free
from HIV or HTLV-1, and about the potential adverse effects of
testing on the sperm.
This bill would remove the requirement that the recipient be
informed of the availability and consequences of further testing.
Under existing law, the physician performing insemination or
advanced reproductive technology is required to provide prophylactic
treatments, follow-up testing, and monitoring, as specified, to the
recipient to minimize the risk of infection.
This bill would remove those requirements.
Existing law allows the use of sperm from a donor who has tested
reactive for HIV or HTLV-1 if the recipient has also previously been
documented with HIV or HTLV-1 and where mutual consent has been
obtained.
This bill would remove this provision. The bill would also make
all of the provisions above applicable to donors who have tested
reactive for any of the human T lymphotrophic viruses.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
AB 1397, as introduced, Hill. Tissue donation.
Existing law prohibits the transfer of any tissues, as defined,
into the body of another person by means of transplantation, unless
the donor of the tissues has been screened and found nonreactive for
evidence of infection with human immunodeficiency virus (HIV), agents
of viral hepatitis (HBV and HCV), human T lymphotrophic virus-1
(HTLV-1), and syphilis, except as provided.
Existing law requires that all donors of sperm be screened and
found nonreactive under the above provisions, except as provided.
Under existing law, a sperm donor who has tested reactive for HIV or
HTLV-1 may be used for insemination or advanced reproductive
technology for a recipient who has tested negative only after
processing to minimize the infectiousness of the sperm. The State
Department of Public Health is required to adopt regulations by
January 1, 2010, regulating facilities that perform this processing.
This bill would, instead, make the adoption of the above
regulations voluntary.
Existing law further requires the physician providing insemination
or advanced reproductive technologies to, among other things, inform
the recipient that the processing may not eliminate the risk of
infection, that the sperm may be tested to ensure that it is free
from HIV or HTLV-1, and about the potential adverse effects of
testing on the sperm.
This bill would remove the requirement that the recipient be
informed of the availability and consequences of further testing.
Under existing law, the physician performing insemination or
advanced reproductive technology is required to provide prophylactic
treatments, follow-up testing, and monitoring, as specified, to the
recipient to minimize the risk of infection.
This bill would remove those requirements.
Existing law allows the use of sperm from a donor who has tested
reactive for HIV or HTLV-1 if the recipient has also previously been
documented with HIV or HTLV-1 and where mutual consent has been
obtained.
This bill would remove this provision. The bill would also make
all of the provisions above applicable to donors who have tested
reactive for any of the human T lymphotrophic viruses.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
AB 1397, as introduced, Hill. Tissue donation.
Existing law prohibits the transfer of any tissues, as defined,
into the body of another person by means of transplantation, unless
the donor of the tissues has been screened and found nonreactive for
evidence of infection with human immunodeficiency virus (HIV), agents
of viral hepatitis (HBV and HCV), human T lymphotrophic virus-1
(HTLV-1), and syphilis, except as provided.
Existing law requires that all donors of sperm be screened and
found nonreactive under the above provisions, except as provided.
Under existing law, a sperm donor who has tested reactive for HIV or
HTLV-1 may be used for insemination or advanced reproductive
technology for a recipient who has tested negative only after
processing to minimize the infectiousness of the sperm. The State
Department of Public Health is required to adopt regulations by
January 1, 2010, regulating facilities that perform this processing.
This bill would, instead, make the adoption of the above
regulations voluntary.
Existing law further requires the physician providing insemination
or advanced reproductive technologies to, among other things, inform
the recipient that the processing may not eliminate the risk of
infection, that the sperm may be tested to ensure that it is free
from HIV or HTLV-1, and about the potential adverse effects of
testing on the sperm.
This bill would remove the requirement that the recipient be
informed of the availability and consequences of further testing.
Under existing law, the physician performing insemination or
advanced reproductive technology is required to provide prophylactic
treatments, follow-up testing, and monitoring, as specified, to the
recipient to minimize the risk of infection.
This bill would remove those requirements.
Existing law allows the use of sperm from a donor who has tested
reactive for HIV or HTLV-1 if the recipient has also previously been
documented with HIV or HTLV-1 and where mutual consent has been
obtained.
This bill would remove this provision. The bill would also make
all of the provisions above applicable to donors who have tested
reactive for any of the human T lymphotrophic viruses.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
AB 1397, as introduced, Hill. Tissue donation.
Existing law prohibits the transfer of any tissues, as defined,
into the body of another person by means of transplantation, unless
the donor of the tissues has been screened and found nonreactive for
evidence of infection with human immunodeficiency virus (HIV), agents
of viral hepatitis (HBV and HCV), human T lymphotrophic virus-1
(HTLV-1), and syphilis, except as provided.
Existing law requires that all donors of sperm be screened and
found nonreactive under the above provisions, except as provided.
Under existing law, a sperm donor who has tested reactive for HIV or
HTLV-1 may be used for insemination or advanced reproductive
technology for a recipient who has tested negative only after
processing to minimize the infectiousness of the sperm. The State
Department of Public Health is required to adopt regulations by
January 1, 2010, regulating facilities that perform this processing.
This bill would, instead, make the adoption of the above
regulations voluntary.
Existing law further requires the physician providing insemination
or advanced reproductive technologies to, among other things, inform
the recipient that the processing may not eliminate the risk of
infection, that the sperm may be tested to ensure that it is free
from HIV or HTLV-1, and about the potential adverse effects of
testing on the sperm.
This bill would remove the requirement that the recipient be
informed of the availability and consequences of further testing.
Under existing law, the physician performing insemination or
advanced reproductive technology is required to provide prophylactic
treatments, follow-up testing, and monitoring, as specified, to the
recipient to minimize the risk of infection.
This bill would remove those requirements.
Existing law allows the use of sperm from a donor who has tested
reactive for HIV or HTLV-1 if the recipient has also previously been
documented with HIV or HTLV-1 and where mutual consent has been
obtained.
This bill would remove this provision. The bill would also make
all of the provisions above applicable to donors who have tested
reactive for any of the human T lymphotrophic viruses.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
AB 1397, as introduced, Hill. Tissue donation.
Existing law prohibits the transfer of any tissues, as defined,
into the body of another person by means of transplantation, unless
the donor of the tissues has been screened and found nonreactive for
evidence of infection with human immunodeficiency virus (HIV), agents
of viral hepatitis (HBV and HCV), human T lymphotrophic virus-1
(HTLV-1), and syphilis, except as provided.
Existing law requires that all donors of sperm be screened and
found nonreactive under the above provisions, except as provided.
Under existing law, a sperm donor who has tested reactive for HIV or
HTLV-1 may be used for insemination or advanced reproductive
technology for a recipient who has tested negative only after
processing to minimize the infectiousness of the sperm. The State
Department of Public Health is required to adopt regulations by
January 1, 2010, regulating facilities that perform this processing.
This bill would, instead, make the adoption of the above
regulations voluntary.
Existing law further requires the physician providing insemination
or advanced reproductive technologies to, among other things, inform
the recipient that the processing may not eliminate the risk of
infection, that the sperm may be tested to ensure that it is free
from HIV or HTLV-1, and about the potential adverse effects of
testing on the sperm.
This bill would remove the requirement that the recipient be
informed of the availability and consequences of further testing.
Under existing law, the physician performing insemination or
advanced reproductive technology is required to provide prophylactic
treatments, follow-up testing, and monitoring, as specified, to the
recipient to minimize the risk of infection.
This bill would remove those requirements.
Existing law allows the use of sperm from a donor who has tested
reactive for HIV or HTLV-1 if the recipient has also previously been
documented with HIV or HTLV-1 and where mutual consent has been
obtained.
This bill would remove this provision. The bill would also make
all of the provisions above applicable to donors who have tested
reactive for any of the human T lymphotrophic viruses.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 1644.5 of the Health and Safety Code is amended
to read:
1644.5. (a) No tissues shall be transferred into the body of
another person by means of transplantation, unless the donor of the
tissues has been screened and found nonreactive by laboratory tests
for evidence of infection with HIV, agents of viral hepatitis (HBV
and HCV), human T lymphotrophic virus-1 (HTLV-1)
virus (HTLV) , and syphilis, except as provided in
subdivision (c). The department may adopt regulations requiring
additional screening tests of donors of tissues when, in the opinion
of the department, the action is necessary for the protection of the
public, donors, or recipients.
(b) Notwithstanding subdivision (a), infectious disease screening
of blood and blood products shall be carried out solely in accordance
with Article 2 (commencing with Section 1601) of Chapter 4.
(c) All donors of sperm shall be screened and found nonreactive as
required under subdivision (a), except in the following instances:
(1) A recipient of sperm, from a sperm donor known to the
recipient, may waive a second or other repeat testing of that donor
if the recipient is informed of the requirements for testing donors
under this section and signs a written waiver.
(2) A recipient of sperm may consent to therapeutic insemination
of sperm or use of sperm in other advanced reproductive technologies
even if the sperm donor is found reactive for hepatitis B, hepatitis
C, syphilis, HIV or HTLV-1 HTLV if the
sperm donor is the spouse of, partner of, or designated donor for
that recipient. The physician providing insemination or advanced
reproductive technology services shall advise the donor and recipient
of the potential medical risks associated with receiving sperm from
a reactive donor. The donor and the recipient shall sign a document
affirming that each comprehends the medical repercussions of using
sperm from a reactive donor for the proposed procedure and that each
consents to it. Copies of the document shall be placed in the medical
records of the donor and the recipient.
(3) (A) Sperm whose donor has tested reactive for syphilis may be
used for the purposes of insemination or advanced reproductive
technology only after the donor has been treated for syphilis. Sperm
whose donor has tested reactive for hepatitis B may be used for the
purposes of insemination or advanced reproductive technology only
after the recipient has been vaccinated against hepatitis B.
(B) (i) Sperm whose donor has tested reactive for HIV or
HTLV-1 HTLV may be used for the purposes of
insemination or advanced reproductive technology for a recipient
testing negative for HIV or HTLV-1 HTLV
only after the donor's sperm has been effectively processed to
minimize the infectiousness of the sperm for that specific donation
and where informed and mutual consent has occurred.
(ii) The department shall may adopt
regulations by January 1, 2010, regulating
facilities that perform sperm processing, pursuant to this
subparagraph, that prescribe standards for the handling and storage
of sperm samples of carriers of HIV, HTLV-1
HTLV , or any other virus as deemed appropriate by the
department. Until the department adopts these
In the absence of regulations, facilities that perform sperm
processing shall follow facility and sperm processing guidelines
developed by the American Society of Reproductive Medicine.
(iii) Prior to insemination or other advanced reproductive
technology services, the physician shall inform the recipient of
sperm from a donor who has tested reactive for HIV or HTLV-1
HTLV that sperm processing may not eliminate
all risks of HIV or HTLV-1 HTLV
transmission , and that the sperm may be tested to determine
whether or not it is free of HIV or HTLV-1. The physician shall also
inform the recipient of potential adverse effects the testing may
have on the processed sperm .
(iv) The physician providing insemination or advanced
reproductive technology services shall provide, as appropriate,
prophylactic treatments, including, but not limited to,
antiretroviral treatments, to the recipient to reduce the risk of
acquiring infection during, and subsequent to, insemination or
advanced reproductive technology. The physician providing
insemination or advanced reproductive technology services
shall also verify, and document in the recipient's medical record,
that the donor of sperm who tests reactive for HIV or HTLV-1
HTLV is under the care of a physician managing
the HIV or HTLV-l to minimize the risk of transmission
during the course of insemination or advanced reproductive technology
services. The physician shall perform appropriate followup testing
of the recipient for HIV or HTLV-1 following the insemination or
other advanced reproductive technology, and recommend ongoing
monitoring by a physician during treatment and pregnancy. The
physician shall also recommend in the sperm recipient's medical
record that the recipient be monitored during treatment and pregnancy
HTLV .
(v) In the event that the recipient tests reactive for
becomes HIV or HTLV-1 following
insemination or other advanced reproductive technology, the physician
HTLV positive during the course of the pregnancy, the
physician assuming ongoing management of the pregnancy shall
inform the recipient of appropriate treatments during and
after pregnancy, and of treatments or procedures that may
reduce the risk of transmission to the offspring , or provide
information regarding referral to a physician who can provide that
information .
(vi) Sperm whose donor has tested reactive for HIV or HTLV-1 may
be used for the purposes of insemination or advanced reproductive
technology if the recipient already has been previously documented
with HIV or HTLV-1 infection, and where informed and mutual consent
has occurred.
(4) The penalties of Section 1621.5 shall not apply to a sperm
donor covered under this subdivision.
(d) Subdivision (a) shall not apply to the transplantation of
tissue from a donor who has not been tested or, with the exception of
HIV and HTLV-1 HTLV , has been found
reactive for the infectious diseases listed in subdivision (a) or for
which the department has, by regulation, required additional
screening tests, if both of the following conditions are satisfied:
(1) The physician and surgeon performing the transplantation has
determined any one or more of the following:
(A) Without the transplantation the intended recipient will most
likely die during the period of time necessary to obtain other tissue
or to conduct the required tests.
(B) The intended recipient already is diagnosed with the
infectious disease for which the donor has tested positive.
(C) The symptoms from the infectious disease for which the donor
has tested positive will most likely not appear during the intended
recipient's likely lifespan after transplantation with the tissue or
may be treated prophylactically if they do appear.
(2) Consent for the use of the tissue has been obtained from the
recipient, if possible, or if not possible, from a member of the
recipient's family, or the recipient's legal guardian. For purposes
of this section, "family" shall mean spouse, adult son or daughter,
either parent, adult brother or sister, or grandparent.
(e) Human breast milk from donors who test reactive for agents of
viral hepatitis (HBV and HCV), human T lymphotrophic virus-1
(HTLV-1) HTLV , HIV, or syphilis shall not be
used for deposit into a milk bank for human ingestion in California.
SECTION 1. Section 1644.5 of the Health and Safety Code is amended
to read:
1644.5. (a) No tissues shall be transferred into the body of
another person by means of transplantation, unless the donor of the
tissues has been screened and found nonreactive by laboratory tests
for evidence of infection with HIV, agents of viral hepatitis (HBV
and HCV), human T lymphotrophic virus-1 (HTLV-1)
virus (HTLV) , and syphilis, except as provided in
subdivision (c). The department may adopt regulations requiring
additional screening tests of donors of tissues when, in the opinion
of the department, the action is necessary for the protection of the
public, donors, or recipients.
(b) Notwithstanding subdivision (a), infectious disease screening
of blood and blood products shall be carried out solely in accordance
with Article 2 (commencing with Section 1601) of Chapter 4.
(c) All donors of sperm shall be screened and found nonreactive as
required under subdivision (a), except in the following instances:
(1) A recipient of sperm, from a sperm donor known to the
recipient, may waive a second or other repeat testing of that donor
if the recipient is informed of the requirements for testing donors
under this section and signs a written waiver.
(2) A recipient of sperm may consent to therapeutic insemination
of sperm or use of sperm in other advanced reproductive technologies
even if the sperm donor is found reactive for hepatitis B, hepatitis
C, syphilis, HIV or HTLV-1 HTLV if the
sperm donor is the spouse of, partner of, or designated donor for
that recipient. The physician providing insemination or advanced
reproductive technology services shall advise the donor and recipient
of the potential medical risks associated with receiving sperm from
a reactive donor. The donor and the recipient shall sign a document
affirming that each comprehends the medical repercussions of using
sperm from a reactive donor for the proposed procedure and that each
consents to it. Copies of the document shall be placed in the medical
records of the donor and the recipient.
(3) (A) Sperm whose donor has tested reactive for syphilis may be
used for the purposes of insemination or advanced reproductive
technology only after the donor has been treated for syphilis. Sperm
whose donor has tested reactive for hepatitis B may be used for the
purposes of insemination or advanced reproductive technology only
after the recipient has been vaccinated against hepatitis B.
(B) (i) Sperm whose donor has tested reactive for HIV or
HTLV-1 HTLV may be used for the purposes of
insemination or advanced reproductive technology for a recipient
testing negative for HIV or HTLV-1 HTLV
only after the donor's sperm has been effectively processed to
minimize the infectiousness of the sperm for that specific donation
and where informed and mutual consent has occurred.
(ii) The department shall may adopt
regulations by January 1, 2010, regulating
facilities that perform sperm processing, pursuant to this
subparagraph, that prescribe standards for the handling and storage
of sperm samples of carriers of HIV, HTLV-1
HTLV , or any other virus as deemed appropriate by the
department. Until the department adopts these
In the absence of regulations, facilities that perform sperm
processing shall follow facility and sperm processing guidelines
developed by the American Society of Reproductive Medicine.
(iii) Prior to insemination or other advanced reproductive
technology services, the physician shall inform the recipient of
sperm from a donor who has tested reactive for HIV or HTLV-1
HTLV that sperm processing may not eliminate
all risks of HIV or HTLV-1 HTLV
transmission , and that the sperm may be tested to determine
whether or not it is free of HIV or HTLV-1. The physician shall also
inform the recipient of potential adverse effects the testing may
have on the processed sperm .
(iv) The physician providing insemination or advanced
reproductive technology services shall provide, as appropriate,
prophylactic treatments, including, but not limited to,
antiretroviral treatments, to the recipient to reduce the risk of
acquiring infection during, and subsequent to, insemination or
advanced reproductive technology. The physician providing
insemination or advanced reproductive technology services
shall also verify, and document in the recipient's medical record,
that the donor of sperm who tests reactive for HIV or HTLV-1
HTLV is under the care of a physician managing
the HIV or HTLV-l to minimize the risk of transmission
during the course of insemination or advanced reproductive technology
services. The physician shall perform appropriate followup testing
of the recipient for HIV or HTLV-1 following the insemination or
other advanced reproductive technology, and recommend ongoing
monitoring by a physician during treatment and pregnancy. The
physician shall also recommend in the sperm recipient's medical
record that the recipient be monitored during treatment and pregnancy
HTLV .
(v) In the event that the recipient tests reactive for
becomes HIV or HTLV-1 following
insemination or other advanced reproductive technology, the physician
HTLV positive during the course of the pregnancy, the
physician assuming ongoing management of the pregnancy shall
inform the recipient of appropriate treatments during and
after pregnancy, and of treatments or procedures that may
reduce the risk of transmission to the offspring , or provide
information regarding referral to a physician who can provide that
information .
(vi) Sperm whose donor has tested reactive for HIV or HTLV-1 may
be used for the purposes of insemination or advanced reproductive
technology if the recipient already has been previously documented
with HIV or HTLV-1 infection, and where informed and mutual consent
has occurred.
(4) The penalties of Section 1621.5 shall not apply to a sperm
donor covered under this subdivision.
(d) Subdivision (a) shall not apply to the transplantation of
tissue from a donor who has not been tested or, with the exception of
HIV and HTLV-1 HTLV , has been found
reactive for the infectious diseases listed in subdivision (a) or for
which the department has, by regulation, required additional
screening tests, if both of the following conditions are satisfied:
(1) The physician and surgeon performing the transplantation has
determined any one or more of the following:
(A) Without the transplantation the intended recipient will most
likely die during the period of time necessary to obtain other tissue
or to conduct the required tests.
(B) The intended recipient already is diagnosed with the
infectious disease for which the donor has tested positive.
(C) The symptoms from the infectious disease for which the donor
has tested positive will most likely not appear during the intended
recipient's likely lifespan after transplantation with the tissue or
may be treated prophylactically if they do appear.
(2) Consent for the use of the tissue has been obtained from the
recipient, if possible, or if not possible, from a member of the
recipient's family, or the recipient's legal guardian. For purposes
of this section, "family" shall mean spouse, adult son or daughter,
either parent, adult brother or sister, or grandparent.
(e) Human breast milk from donors who test reactive for agents of
viral hepatitis (HBV and HCV), human T lymphotrophic virus-1
(HTLV-1) HTLV , HIV, or syphilis shall not be
used for deposit into a milk bank for human ingestion in California.
SECTION 1. Section 1644.5 of the Health and Safety Code is amended
to read:
1644.5. (a) No tissues shall be transferred into the body of
another person by means of transplantation, unless the donor of the
tissues has been screened and found nonreactive by laboratory tests
for evidence of infection with HIV, agents of viral hepatitis (HBV
and HCV), human T lymphotrophic virus-1 (HTLV-1)
virus (HTLV) , and syphilis, except as provided in
subdivision (c). The department may adopt regulations requiring
additional screening tests of donors of tissues when, in the opinion
of the department, the action is necessary for the protection of the
public, donors, or recipients.
(b) Notwithstanding subdivision (a), infectious disease screening
of blood and blood products shall be carried out solely in accordance
with Article 2 (commencing with Section 1601) of Chapter 4.
(c) All donors of sperm shall be screened and found nonreactive as
required under subdivision (a), except in the following instances:
(1) A recipient of sperm, from a sperm donor known to the
recipient, may waive a second or other repeat testing of that donor
if the recipient is informed of the requirements for testing donors
under this section and signs a written waiver.
(2) A recipient of sperm may consent to therapeutic insemination
of sperm or use of sperm in other advanced reproductive technologies
even if the sperm donor is found reactive for hepatitis B, hepatitis
C, syphilis, HIV or HTLV-1 HTLV if the
sperm donor is the spouse of, partner of, or designated donor for
that recipient. The physician providing insemination or advanced
reproductive technology services shall advise the donor and recipient
of the potential medical risks associated with receiving sperm from
a reactive donor. The donor and the recipient shall sign a document
affirming that each comprehends the medical repercussions of using
sperm from a reactive donor for the proposed procedure and that each
consents to it. Copies of the document shall be placed in the medical
records of the donor and the recipient.
(3) (A) Sperm whose donor has tested reactive for syphilis may be
used for the purposes of insemination or advanced reproductive
technology only after the donor has been treated for syphilis. Sperm
whose donor has tested reactive for hepatitis B may be used for the
purposes of insemination or advanced reproductive technology only
after the recipient has been vaccinated against hepatitis B.
(B) (i) Sperm whose donor has tested reactive for HIV or
HTLV-1 HTLV may be used for the purposes of
insemination or advanced reproductive technology for a recipient
testing negative for HIV or HTLV-1 HTLV
only after the donor's sperm has been effectively processed to
minimize the infectiousness of the sperm for that specific donation
and where informed and mutual consent has occurred.
(ii) The department shall may adopt
regulations by January 1, 2010, regulating
facilities that perform sperm processing, pursuant to this
subparagraph, that prescribe standards for the handling and storage
of sperm samples of carriers of HIV, HTLV-1
HTLV , or any other virus as deemed appropriate by the
department. Until the department adopts these
In the absence of regulations, facilities that perform sperm
processing shall follow facility and sperm processing guidelines
developed by the American Society of Reproductive Medicine.
(iii) Prior to insemination or other advanced reproductive
technology services, the physician shall inform the recipient of
sperm from a donor who has tested reactive for HIV or HTLV-1
HTLV that sperm processing may not eliminate
all risks of HIV or HTLV-1 HTLV
transmission , and that the sperm may be tested to determine
whether or not it is free of HIV or HTLV-1. The physician shall also
inform the recipient of potential adverse effects the testing may
have on the processed sperm .
(iv) The physician providing insemination or advanced
reproductive technology services shall provide, as appropriate,
prophylactic treatments, including, but not limited to,
antiretroviral treatments, to the recipient to reduce the risk of
acquiring infection during, and subsequent to, insemination or
advanced reproductive technology. The physician providing
insemination or advanced reproductive technology services
shall also verify, and document in the recipient's medical record,
that the donor of sperm who tests reactive for HIV or HTLV-1
HTLV is under the care of a physician managing
the HIV or HTLV-l to minimize the risk of transmission
during the course of insemination or advanced reproductive technology
services. The physician shall perform appropriate followup testing
of the recipient for HIV or HTLV-1 following the insemination or
other advanced reproductive technology, and recommend ongoing
monitoring by a physician during treatment and pregnancy. The
physician shall also recommend in the sperm recipient's medical
record that the recipient be monitored during treatment and pregnancy
HTLV .
(v) In the event that the recipient tests reactive for
becomes HIV or HTLV-1 following
insemination or other advanced reproductive technology, the physician
HTLV positive during the course of the pregnancy, the
physician assuming ongoing management of the pregnancy shall
inform the recipient of appropriate treatments during and
after pregnancy, and of treatments or procedures that may
reduce the risk of transmission to the offspring , or provide
information regarding referral to a physician who can provide that
information .
(vi) Sperm whose donor has tested reactive for HIV or HTLV-1 may
be used for the purposes of insemination or advanced reproductive
technology if the recipient already has been previously documented
with HIV or HTLV-1 infection, and where informed and mutual consent
has occurred.
(4) The penalties of Section 1621.5 shall not apply to a sperm
donor covered under this subdivision.
(d) Subdivision (a) shall not apply to the transplantation of
tissue from a donor who has not been tested or, with the exception of
HIV and HTLV-1 HTLV , has been found
reactive for the infectious diseases listed in subdivision (a) or for
which the department has, by regulation, required additional
screening tests, if both of the following conditions are satisfied:
(1) The physician and surgeon performing the transplantation has
determined any one or more of the following:
(A) Without the transplantation the intended recipient will most
likely die during the period of time necessary to obtain other tissue
or to conduct the required tests.
(B) The intended recipient already is diagnosed with the
infectious disease for which the donor has tested positive.
(C) The symptoms from the infectious disease for which the donor
has tested positive will most likely not appear during the intended
recipient's likely lifespan after transplantation with the tissue or
may be treated prophylactically if they do appear.
(2) Consent for the use of the tissue has been obtained from the
recipient, if possible, or if not possible, from a member of the
recipient's family, or the recipient's legal guardian. For purposes
of this section, "family" shall mean spouse, adult son or daughter,
either parent, adult brother or sister, or grandparent.
(e) Human breast milk from donors who test reactive for agents of
viral hepatitis (HBV and HCV), human T lymphotrophic virus-1
(HTLV-1) HTLV , HIV, or syphilis shall not be
used for deposit into a milk bank for human ingestion in California.
SECTION 1. Section 1644.5 of the Health and Safety Code is amended
to read:
1644.5. (a) No tissues shall be transferred into the body of
another person by means of transplantation, unless the donor of the
tissues has been screened and found nonreactive by laboratory tests
for evidence of infection with HIV, agents of viral hepatitis (HBV
and HCV), human T lymphotrophic virus-1 (HTLV-1)
virus (HTLV) , and syphilis, except as provided in
subdivision (c). The department may adopt regulations requiring
additional screening tests of donors of tissues when, in the opinion
of the department, the action is necessary for the protection of the
public, donors, or recipients.
(b) Notwithstanding subdivision (a), infectious disease screening
of blood and blood products shall be carried out solely in accordance
with Article 2 (commencing with Section 1601) of Chapter 4.
(c) All donors of sperm shall be screened and found nonreactive as
required under subdivision (a), except in the following instances:
(1) A recipient of sperm, from a sperm donor known to the
recipient, may waive a second or other repeat testing of that donor
if the recipient is informed of the requirements for testing donors
under this section and signs a written waiver.
(2) A recipient of sperm may consent to therapeutic insemination
of sperm or use of sperm in other advanced reproductive technologies
even if the sperm donor is found reactive for hepatitis B, hepatitis
C, syphilis, HIV or HTLV-1 HTLV if the
sperm donor is the spouse of, partner of, or designated donor for
that recipient. The physician providing insemination or advanced
reproductive technology services shall advise the donor and recipient
of the potential medical risks associated with receiving sperm from
a reactive donor. The donor and the recipient shall sign a document
affirming that each comprehends the medical repercussions of using
sperm from a reactive donor for the proposed procedure and that each
consents to it. Copies of the document shall be placed in the medical
records of the donor and the recipient.
(3) (A) Sperm whose donor has tested reactive for syphilis may be
used for the purposes of insemination or advanced reproductive
technology only after the donor has been treated for syphilis. Sperm
whose donor has tested reactive for hepatitis B may be used for the
purposes of insemination or advanced reproductive technology only
after the recipient has been vaccinated against hepatitis B.
(B) (i) Sperm whose donor has tested reactive for HIV or
HTLV-1 HTLV may be used for the purposes of
insemination or advanced reproductive technology for a recipient
testing negative for HIV or HTLV-1 HTLV
only after the donor's sperm has been effectively processed to
minimize the infectiousness of the sperm for that specific donation
and where informed and mutual consent has occurred.
(ii) The department shall may adopt
regulations by January 1, 2010, regulating
facilities that perform sperm processing, pursuant to this
subparagraph, that prescribe standards for the handling and storage
of sperm samples of carriers of HIV, HTLV-1
HTLV , or any other virus as deemed appropriate by the
department. Until the department adopts these
In the absence of regulations, facilities that perform sperm
processing shall follow facility and sperm processing guidelines
developed by the American Society of Reproductive Medicine.
(iii) Prior to insemination or other advanced reproductive
technology services, the physician shall inform the recipient of
sperm from a donor who has tested reactive for HIV or HTLV-1
HTLV that sperm processing may not eliminate
all risks of HIV or HTLV-1 HTLV
transmission , and that the sperm may be tested to determine
whether or not it is free of HIV or HTLV-1. The physician shall also
inform the recipient of potential adverse effects the testing may
have on the processed sperm .
(iv) The physician providing insemination or advanced
reproductive technology services shall provide, as appropriate,
prophylactic treatments, including, but not limited to,
antiretroviral treatments, to the recipient to reduce the risk of
acquiring infection during, and subsequent to, insemination or
advanced reproductive technology. The physician providing
insemination or advanced reproductive technology services
shall also verify, and document in the recipient's medical record,
that the donor of sperm who tests reactive for HIV or HTLV-1
HTLV is under the care of a physician managing
the HIV or HTLV-l to minimize the risk of transmission
during the course of insemination or advanced reproductive technology
services. The physician shall perform appropriate followup testing
of the recipient for HIV or HTLV-1 following the insemination or
other advanced reproductive technology, and recommend ongoing
monitoring by a physician during treatment and pregnancy. The
physician shall also recommend in the sperm recipient's medical
record that the recipient be monitored during treatment and pregnancy
HTLV .
(v) In the event that the recipient tests reactive for
becomes HIV or HTLV-1 following
insemination or other advanced reproductive technology, the physician
HTLV positive during the course of the pregnancy, the
physician assuming ongoing management of the pregnancy shall
inform the recipient of appropriate treatments during and
after pregnancy, and of treatments or procedures that may
reduce the risk of transmission to the offspring , or provide
information regarding referral to a physician who can provide that
information .
(vi) Sperm whose donor has tested reactive for HIV or HTLV-1 may
be used for the purposes of insemination or advanced reproductive
technology if the recipient already has been previously documented
with HIV or HTLV-1 infection, and where informed and mutual consent
has occurred.
(4) The penalties of Section 1621.5 shall not apply to a sperm
donor covered under this subdivision.
(d) Subdivision (a) shall not apply to the transplantation of
tissue from a donor who has not been tested or, with the exception of
HIV and HTLV-1 HTLV , has been found
reactive for the infectious diseases listed in subdivision (a) or for
which the department has, by regulation, required additional
screening tests, if both of the following conditions are satisfied:
(1) The physician and surgeon performing the transplantation has
determined any one or more of the following:
(A) Without the transplantation the intended recipient will most
likely die during the period of time necessary to obtain other tissue
or to conduct the required tests.
(B) The intended recipient already is diagnosed with the
infectious disease for which the donor has tested positive.
(C) The symptoms from the infectious disease for which the donor
has tested positive will most likely not appear during the intended
recipient's likely lifespan after transplantation with the tissue or
may be treated prophylactically if they do appear.
(2) Consent for the use of the tissue has been obtained from the
recipient, if possible, or if not possible, from a member of the
recipient's family, or the recipient's legal guardian. For purposes
of this section, "family" shall mean spouse, adult son or daughter,
either parent, adult brother or sister, or grandparent.
(e) Human breast milk from donors who test reactive for agents of
viral hepatitis (HBV and HCV), human T lymphotrophic virus-1
(HTLV-1) HTLV , HIV, or syphilis shall not be
used for deposit into a milk bank for human ingestion in California.
SECTION 1. Section 1644.5 of the Health and Safety Code is amended
to read:
1644.5. (a) No tissues shall be transferred into the body of
another person by means of transplantation, unless the donor of the
tissues has been screened and found nonreactive by laboratory tests
for evidence of infection with HIV, agents of viral hepatitis (HBV
and HCV), human T lymphotrophic virus-1 (HTLV-1)
virus (HTLV) , and syphilis, except as provided in
subdivision (c). The department may adopt regulations requiring
additional screening tests of donors of tissues when, in the opinion
of the department, the action is necessary for the protection of the
public, donors, or recipients.
(b) Notwithstanding subdivision (a), infectious disease screening
of blood and blood products shall be carried out solely in accordance
with Article 2 (commencing with Section 1601) of Chapter 4.
(c) All donors of sperm shall be screened and found nonreactive as
required under subdivision (a), except in the following instances:
(1) A recipient of sperm, from a sperm donor known to the
recipient, may waive a second or other repeat testing of that donor
if the recipient is informed of the requirements for testing donors
under this section and signs a written waiver.
(2) A recipient of sperm may consent to therapeutic insemination
of sperm or use of sperm in other advanced reproductive technologies
even if the sperm donor is found reactive for hepatitis B, hepatitis
C, syphilis, HIV or HTLV-1 HTLV if the
sperm donor is the spouse of, partner of, or designated donor for
that recipient. The physician providing insemination or advanced
reproductive technology services shall advise the donor and recipient
of the potential medical risks associated with receiving sperm from
a reactive donor. The donor and the recipient shall sign a document
affirming that each comprehends the medical repercussions of using
sperm from a reactive donor for the proposed procedure and that each
consents to it. Copies of the document shall be placed in the medical
records of the donor and the recipient.
(3) (A) Sperm whose donor has tested reactive for syphilis may be
used for the purposes of insemination or advanced reproductive
technology only after the donor has been treated for syphilis. Sperm
whose donor has tested reactive for hepatitis B may be used for the
purposes of insemination or advanced reproductive technology only
after the recipient has been vaccinated against hepatitis B.
(B) (i) Sperm whose donor has tested reactive for HIV or
HTLV-1 HTLV may be used for the purposes of
insemination or advanced reproductive technology for a recipient
testing negative for HIV or HTLV-1 HTLV
only after the donor's sperm has been effectively processed to
minimize the infectiousness of the sperm for that specific donation
and where informed and mutual consent has occurred.
(ii) The department shall may adopt
regulations by January 1, 2010, regulating
facilities that perform sperm processing, pursuant to this
subparagraph, that prescribe standards for the handling and storage
of sperm samples of carriers of HIV, HTLV-1
HTLV , or any other virus as deemed appropriate by the
department. Until the department adopts these
In the absence of regulations, facilities that perform sperm
processing shall follow facility and sperm processing guidelines
developed by the American Society of Reproductive Medicine.
(iii) Prior to insemination or other advanced reproductive
technology services, the physician shall inform the recipient of
sperm from a donor who has tested reactive for HIV or HTLV-1
HTLV that sperm processing may not eliminate
all risks of HIV or HTLV-1 HTLV
transmission , and that the sperm may be tested to determine
whether or not it is free of HIV or HTLV-1. The physician shall also
inform the recipient of potential adverse effects the testing may
have on the processed sperm .
(iv) The physician providing insemination or advanced
reproductive technology services shall provide, as appropriate,
prophylactic treatments, including, but not limited to,
antiretroviral treatments, to the recipient to reduce the risk of
acquiring infection during, and subsequent to, insemination or
advanced reproductive technology. The physician providing
insemination or advanced reproductive technology services
shall also verify, and document in the recipient's medical record,
that the donor of sperm who tests reactive for HIV or HTLV-1
HTLV is under the care of a physician managing
the HIV or HTLV-l to minimize the risk of transmission
during the course of insemination or advanced reproductive technology
services. The physician shall perform appropriate followup testing
of the recipient for HIV or HTLV-1 following the insemination or
other advanced reproductive technology, and recommend ongoing
monitoring by a physician during treatment and pregnancy. The
physician shall also recommend in the sperm recipient's medical
record that the recipient be monitored during treatment and pregnancy
HTLV .
(v) In the event that the recipient tests reactive for
becomes HIV or HTLV-1 following
insemination or other advanced reproductive technology, the physician
HTLV positive during the course of the pregnancy, the
physician assuming ongoing management of the pregnancy shall
inform the recipient of appropriate treatments during and
after pregnancy, and of treatments or procedures that may
reduce the risk of transmission to the offspring , or provide
information regarding referral to a physician who can provide that
information .
(vi) Sperm whose donor has tested reactive for HIV or HTLV-1 may
be used for the purposes of insemination or advanced reproductive
technology if the recipient already has been previously documented
with HIV or HTLV-1 infection, and where informed and mutual consent
has occurred.
(4) The penalties of Section 1621.5 shall not apply to a sperm
donor covered under this subdivision.
(d) Subdivision (a) shall not apply to the transplantation of
tissue from a donor who has not been tested or, with the exception of
HIV and HTLV-1 HTLV , has been found
reactive for the infectious diseases listed in subdivision (a) or for
which the department has, by regulation, required additional
screening tests, if both of the following conditions are satisfied:
(1) The physician and surgeon performing the transplantation has
determined any one or more of the following:
(A) Without the transplantation the intended recipient will most
likely die during the period of time necessary to obtain other tissue
or to conduct the required tests.
(B) The intended recipient already is diagnosed with the
infectious disease for which the donor has tested positive.
(C) The symptoms from the infectious disease for which the donor
has tested positive will most likely not appear during the intended
recipient's likely lifespan after transplantation with the tissue or
may be treated prophylactically if they do appear.
(2) Consent for the use of the tissue has been obtained from the
recipient, if possible, or if not possible, from a member of the
recipient's family, or the recipient's legal guardian. For purposes
of this section, "family" shall mean spouse, adult son or daughter,
either parent, adult brother or sister, or grandparent.
(e) Human breast milk from donors who test reactive for agents of
viral hepatitis (HBV and HCV), human T lymphotrophic virus-1
(HTLV-1) HTLV , HIV, or syphilis shall not be
used for deposit into a milk bank for human ingestion in California.